University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit

北卡罗来纳大学全球艾滋病毒预防和治疗临床试验单位

• 批准号: 10531539
• 负责人: Joseph J Eron
• 金额: $ 409.15万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10531539
• 关键词: AIDS prevention; Adherence; Adolescent; Adult; Affect; Africa; African; Area; Caring; Cells; Child; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Network; Clinical Trials Support Unit; Clinical Trials Unit; Collaborations; Communication; Communities; Complex; Dedications; Development; Disease remission; Doctor of Philosophy; Drug Kinetics; Drug resistance in tuberculosis; Enrollment; Epidemic; Female Adolescents; Goals; HIV; HIV Antibodies; HIV drug resistance; HIV vaccine; HIV/AIDS; HIV/TB; Hepatitis B; Hepatitis B Virus; Incidence; Individual; Infant; Injecting drug user; International; Intervention; Investigation; Laboratories; Lead; Leadership; Malawi; Mind; Mother-to-child HIV transmission; National Institute of Allergy and Infectious Disease; Newly Diagnosed; North Carolina; Nucleosides; Participant; Patient Recruitments; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Population; Populations at Risk; Positioning Attribute; Pregnant Women; Prevention; Prevention trial; Principal Investigator; Public Health; Race; Recording of previous events; Research; Research Personnel; Risk; Sampling; Science; Scientist; Senior Scientist; Southeastern Asia; Southern Africa; Talents; Testing; Therapeutic; Therapeutic Clinical Trial; Tuberculosis; Tuberculosis Vaccines; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Vietnam; Virus; Virus Activation; Work; acute infection; antiretroviral therapy; black women; clinical research site; co-infection; community engagement; comorbidity; data management; early phase trial; experience; follow-up; gender diversity; high risk; high risk population; innovation; men of color; men who have sex with men; novel; organizational structure; participant retention; pathogen; phase 3 study; pre-exposure prophylaxis; pregnant; prevention clinical trial; recruit; skills; transgender women; translational scientist; treatment as prevention; treatment trial; vaccine trial; viral rebound; virtual; volunteer; young man; young men who have sex with men; young woman

Abstract The University of North Carolina (UNC) Global HIV Prevention and Treatment Clinical Trials Unit (CTU) has a well-established record of high quality, innovative clinical research, strong network and scientific leadership. The CTU engages with critically important populations infected with and at high risk of HIV in southeastern US, southern Africa and southeast Asia. Our CTU is led by three experienced principal investigators (Joseph Eron MD, Mina Hosseinipour MD and David Wohl MD) and will support all four NIH Clinical Trials Networks (CTN); Adult Therapeutic Strategies, HIV Prevention, Vaccine Prevention and Pediatric, Adolescent and Maternal Therapeutic Strategies. Our four experienced Clinical Research Sites (CRS) include Chapel Hill CRS (Adult Strategies, Prevention and Vaccine CTN) led by Dr. Wohl, Greensboro CRS (Adult Strategies, Prevention and Vaccine CTN) led by Cornelius Van Dam MD, Malawi CRS (all four CTN) led by Lameck Chinula MD and Vietnam CRS (Adult Strategies, Prevention and Vaccine CTN) led by Vivian Go PhD. Participants with HIV include those newly diagnosed (including with acute infection), PWH stably suppressed on therapy and PWH with adherence challenges to care or medication and those with drug-resistant HIV. At-risk populations include men who have sex with men (MSM) including young men of color, transgender women (TGW), people who inject drugs (PWID) and African adolescent girls and women including those who are pregnant. We will enroll PWH at risk for comorbidities and PWH or without HIV with co-epidemic pathogens such as tuberculosis (TB) and Hepatitis B virus (HBV). We have skilled, experienced clinical and translational investigators working hand-in-hand with junior investigators with diversity of gender and race, in US and international settings, who will engage and execute the network scientific agenda. A globally representative set of senior scientists and public health leaders on our Scientific and Strategic Advisory Group advise the CTU leadership team. The CTU administration has a highly organized structure that is responsive to our research teams and CRSs. Each CRS engages the communities representing the affected populations in an interactive, open-minded way. State-of-art communication and experienced, outstanding and well-organized laboratory, pharmacy, regulatory, quality and data management support the CTU, CRSs. Using this robust framework the UNC Global CTU is positioned optimally to continue our scientific, and network leadership and clinical trials support to the agenda of all four NIH HIV networks.

摘要